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Page 288
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[Manufacturing project management]
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changing demands of each phase of product development, 238-244
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full commercialization, 243
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molecule selection, 238, 239
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patent expiry defense strategy, 243, 244
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phase II/III, 241, 242
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phase IV/launch, 242, 243
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preclinical phase I/II, 239-241
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conflicting objectives, 237, 238
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interlocking project structure, 244-246
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key issues facing, 236
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manufacturing philosophy, 236, 237
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manufacturing project management group, 246-248
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technical support structure, 248-251
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worldwide production, 251, 252
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Mechanical testing of drug delivery devices, 197
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Miniaturization, 22
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Monte Carlo simulation, 36-38
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Multiattribute analysis, 37-39
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Multidisciplinary teamwork for clinical research projects, 205, 206, 216
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Multiproject planning, information systems for, 78, 79
N
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Network plans, 72, 73
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Network software for project planning, 77-80
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New percent value (NPV), 39, 42
O
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Open data base connectivity (ODBC) for single project systems, 78
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Optimizing the project plan, 61-70
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clinical development, 68, 69
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manufacturing development, 69, 70
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phase I, 67, 68
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toxicology and safety investigations, 66, 67
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Option pricing analysis, 38, 39
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Organizational concerns raised by portfolio review process, 47, 48
P
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Personal productivity tool
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IT as, 264
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Pharmacoeconomics
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Interest groups, 16
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PICAS data base, 224, 225
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Portfolio review and analysis, 25-49
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data gathering and review, 32-34
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IT as aid to portfolio management, 281, 282
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link between strategic goals and operational plans, 27
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organizational issues, 47, 48
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overview of portfolio review process, 28, 29
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results, 39-47
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resources and costs, 43-45
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risk/reward, 39-43
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strategic issues, 45-49
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review inputs, 29-32
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commercial attractiveness, 31, 32
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R&D feasibility, 30
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research potential, 29, 30
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resources and costs, 30, 31
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review methodologies, 34-38

 
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